This disclosure relates generally to the field of implantable medical devices and treatment methods, and more particularly to vasculature devices and methods for closing openings in vessel walls.
During certain types of vascular surgery, catheters are inserted through an incision in the skin and underlying tissue to access an artery, such as the femoral artery, as one example. After the surgical procedure is completed and the catheter is removed from the patient, the access hole must be closed. This is quite difficult, not only because of the high blood pressure in the artery, but also because there are many layers of tissue that must be penetrated to reach the femoral artery.
Physicians currently use a number of methods to close the artery access hole, such as localized compression, sutures, collagen plugs, adhesives, gels, foams, and/or other similar materials. To provide localized compression, the physician presses down against the vessel to allow the artery access hole to naturally clot. This method, however, can take half an hour or more, and requires the patient to remain immobilized for at least that period of time and be subsequently kept in the hospital for observation. In addition, this procedure increases the potential for clots at the puncture site to become dislodged. Moreover, the amount of time necessary for the compression can be significantly greater, depending upon how much heparin, glycoprotein IIb/IIA antagonists, or other anti-clotting agents were used during the procedure. Sutures, collagen plugs, adhesives, gels, and foams may have procedure variability, may require time to close the vessel, may have negative cost factors, may necessitate a possibly complicated deployment process, and may necessitate a separate deployment device.
For newer endovascular procedures, such as abdominal or thoracic aortic aneurysm repair, percutaneous valve replacement and repair, or cardiac ablation, which use large bore delivery systems typically in the range of 8-25 Fr, existing closure methods are suboptimal.
Certain devices and methods have been developed for closing openings in vessel walls. For example, U.S. Patent Application Publication No. 2011/0087270 to Penner et al. provides various examples of vasculature closure devices and methods for deploying and performing treatment using the same.
There remains a need for improved vasculature closure devices and methods for deploying and performing treatment using the same. It would, therefore, be advantageous to provide a vasculature closure device (VCD) that would more quickly and effectively close openings (e.g., punctures) in vessel walls. Such a device would advantageously avoid, or at least substantially reduce, the aforementioned time and expense of applying manual pressure to the opening, simplify the steps required to close the opening, avoid widening of the opening, and more effectively retain the closure device in the vessel. A more effective, safer, and easier to deliver closure device may also be beneficial for smaller sheath accesses, such as those used for cardiac catheterization (e.g., usually 4-8 Fr).